Trial centers on patent of drug that funded chemistry building

By W. Raymond Ollwerther '71
Published in the October 13, 2010, issue

The University is a party in a lawsuit scheduled for trial in November involving patent protection for the cancer drug Alimta, whose royalties have supported construction of Princeton’s new chemistry building.

The University holds the patent for Alimta, which was invented by chemistry professor emeritus Edward C. Taylor. Taylor developed the drug in collaboration with Eli Lilly and Co. scientists to treat malignant pleural mesothelioma, a lung cancer often caused by exposure to asbestos. Approved by the U.S. Food and Drug Administration in 2004, the drug has received additional approvals for first- and second-line lung cancer. Lilly has an exclusive license for the patent.

Though the original patent for Alimta was scheduled to expire in September 2011, Princeton received a patent extension until July 2016 because of the time required to obtain FDA approval.

Lilly and Princeton filed suit against three manufacturers of generic drugs — Teva Parenteral Medicines, Barr Laboratories, and APP Pharmaceuticals — to block their efforts to manufacture and market a generic version of Alimta. The generic manufacturers claim that the patent is invalid.

In a case scheduled for trial Nov. 8 in Wilmington, Del., the University and Lilly are asking U.S. District Court Judge Gregory Sleet to rule that the generic manufacturers have infringed on the patent by seeking FDA approval. Lilly and Princeton are seeking an injunction barring the manufacture or sale of a generic version of Alimta until the patent has expired.

Lilly believes the challenges by the generic drug manufacturers are “without merit,” it said in a report filed with the Securities and Exchange Commission (SEC).

Cass Cliatt ’96, the University’s director of news and editorial services, told The Daily Princetonian last year that the primary issue “is that Alimta is an anti-cancer drug developed based on basic research here at the University. We can’t think of a better public benefit than that…”

According to Lilly’s SEC filings, Alimta had worldwide sales in 2009 of $1.71 billion, up 48 percent from the previous year. Its six-month sales ending June 30 of this year were $1.079 billion, up 50 percent from the same period last year. The company’s licensing agreement with Princeton provides for royalties “of a single-digit percentage of net sales,” according to Lilly’s annual report filed with the SEC.

In her President’s Page in the April 1, 2009, issue of PAW, President Tilghman said that the cost of constructing the new Frick Chemistry Lab “is being completely financed by royalties” from Alimta, which she described as a “wonder drug.”

1 Response
to Trial centers on patent of drug that funded chemistry building

Dan Feigelson '90 Says:

2010-11-02 14:15:53

No surprise here for those of us who work as patent attorneys in the pharma field, but it's a shame that there's a patent challenge to nearly every FDA-approved drug. This article was the impetus for me finally put up a blog post that I've been meaning to put up for months (www.iliplaw.com).